Status:
WITHDRAWN
Dexmedetomidine Sublingual Film for the Management of Agitation in Delirium: Safety and Preliminary Efficacy
Lead Sponsor:
Jeff C. Huffman, MD
Collaborating Sponsors:
BioXcel Therapeutics Inc
Conditions:
Delirium
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The investigator will examine the safety, tolerability, optimal dose, and preliminary efficacy of dexmedetomidine sublingual film in a randomized, double-blind, controlled trial in 40 hospitalized pat...
Detailed Description
Study Intervention Participants will be randomized to receive either 20 mcg or 60 mcg of dexmedetomidine sublingually. Participants will receive repeat dosing every 30 minutes for up to three additio...
Eligibility Criteria
Inclusion
- Adults hospitalized on a medical or surgical intensive care unit at MGH
- Diagnosis of delirium, assessed according to DSM-5 criteria (DSM-5)
- Body mass index (BMI) between 18 and 30 kg/m2, inclusive, at screening
- Weight at least 60 kg (132 pounds), at screening
- In the opinion of the study and clinical teams, sufficiently physically healthy to receive dexmedetomidine sublingual film
Exclusion
- Per medical record or team report, diagnoses of:
- Dementia
- Significant traumatic brain injury
- History of stroke, with persistent neurologic deficits
- Presence of any of the following cardiovascular comorbidities
- Sick sinus syndrome
- A resting heart rate of \< 55 beats per minutes or systolic blood pressure (BP) \<100 mmHg or \>160 mmHg or diastolic BP \<70 mmHg or ˃ 95 mmHg at enrollment and prior to dosing.
- Evidence of cardiac ischemia on a 12-lead electrocardiogram (ECG)
- Corrected QT interval of \> 450 msec
- Presence of a permanent pacemaker device
- Per medical record (notes, current medications, flowsheets):
- Second degree (or greater) Atrioventricular (AV) block without a pacemaker
- Known allergy or adverse reaction to dexmedetomidine
- Current use of dexmedetomidine
- Inability to take sublingual dexmedetomidine due to severe agitation, neurological impairment, nil per os (NPO) status, or other cause.
- Hepatic impairment (liver function tests \> 3 times the upper limit of normal)
- Severe renal impairment (glomerular filtration rate (GFR) \< 30 ml/min or on dialysis)
- Weight \< 60 kg
- Pregnancy (in women; tested with serum or urine human chorionic gonadotropin \[hCG\])
- Non-fluency in English
- Prior enrollment in the study, with receipt of study medication, during the current or a previous hospitalization
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04382170
Start Date
June 1 2020
End Date
June 1 2021
Last Update
May 13 2024
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